Aztreonam Injection

Brand(s)
Azactam
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2013-06-17)
Oldest Current Product
2009-06-01
License(s)
NDA, ANDA
RxNORM
INJECTION\AZTREONAM
FDAOB
INJECTION\INJECTION\AZTREONAM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\AZTREONAM
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZTREONAM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\AZTREONAM
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZTREONAM

product(s) by strength(s)

aztreonam 1000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000032560AzactamNDAE.R. Squibb & Sons, L.L.C.2010-04-01AZTREONAMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA0505809a105eaf-ee77-4016-beeb-d425a5565db2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230401ANDAApp Pharmaceuticals, Llc2009-11-05AZTREONAMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065439302fd27d-0a22-44ea-91fb-1b1ffcf17a1f, 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18, c6cf7e13-a04e-47e2-9cec-44a278ee6bec

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541054AzactamNDACardinal Health2009-06-01AZTREONAMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTION514790041NDA050580d598f95b-92dd-4ef5-ae97-d68972258e44

aztreonam 2000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000032570AzactamNDAE.R. Squibb & Sons, L.L.C.2010-04-01AZTREONAMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA0505809a105eaf-ee77-4016-beeb-d425a5565db2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230402ANDAApp Pharmaceuticals, Llc2009-11-05AZTREONAMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065439302fd27d-0a22-44ea-91fb-1b1ffcf17a1f, 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18, c6cf7e13-a04e-47e2-9cec-44a278ee6bec

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA065286AZTREONAMEUROHEALTH INTERNATIONAL SARL2011-03-23ANDA065286_001, ANDA065286_002
2ANDA065439AZTREONAMFRESENIUS KABI USA LLC2010-06-18ANDA065439_001, ANDA065439_002, ANDA065439_003
3NDA050580AZACTAMBRISTOL MYERS SQUIBB1986-12-31NDA050580_001, NDA050580_002, NDA050580_003
4NDA050632AZACTAM IN PLASTIC CONTAINERBRISTOL MYERS SQUIBB CO1989-05-24NDA050632_001, NDA050632_002, NDA050632_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA065286_001RXAZTREONAM (1GM/VIAL)INJECTIONFalseAP2011-03-23AZTREONAM
2ANDA065286_002RXAZTREONAM (2GM/VIAL)INJECTIONFalseAP2011-03-23AZTREONAM
3ANDA065439_001RXAZTREONAM (500MG/VIAL)INJECTIONFalse2010-06-18AZTREONAM
4ANDA065439_002RXAZTREONAM (1GM/VIAL)INJECTIONFalseAP2010-06-18AZTREONAM
5ANDA065439_003RXAZTREONAM (2GM/VIAL)INJECTIONFalseAP2010-06-18AZTREONAM
6NDA050580_001discontinuedAZTREONAM (500MG/VIAL)INJECTIONFalse1986-12-31AZACTAM
7NDA050580_002RXAZTREONAM (1GM/VIAL)INJECTIONTrueAP1986-12-31AZACTAM
8NDA050580_003RXAZTREONAM (2GM/VIAL)INJECTIONTrueAP1986-12-31AZACTAM
9NDA050632_001RXAZTREONAM (40MG/ML)INJECTIONTrue1989-05-24AZACTAM IN PLASTIC CONTAINER
10NDA050632_002RXAZTREONAM (20MG/ML)INJECTIONTrue1989-05-24AZACTAM IN PLASTIC CONTAINER
11NDA050632_003discontinuedAZTREONAM (10MG/ML)INJECTIONFalse1989-05-24AZACTAM IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b11750e-4db4-4dd3-8b21-c9917b00aeaa (view SPL)AZACTAM (aztreonam injection)in GALAXY Plastic Container (PL 2040) for Intravenous UseprescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2013-06-175000032230, 000032240
2302fd27d-0a22-44ea-91fb-1b1ffcf17a1f (view SPL)Aztreonam for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-03-021633230401, 633230402
35f5ebb63-6ac5-4fb4-bcc1-d069c123eb18 (view SPL)Aztreonam for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-232633230401, 633230402
49a105eaf-ee77-4016-beeb-d425a5565db2 (view SPL)AZACTAM (aztreonam for injection, USP)prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2013-06-173000032560, 000032570
5c6cf7e13-a04e-47e2-9cec-44a278ee6bec (view SPL)Aztreonam for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-03-024633230401, 633230402
6d598f95b-92dd-4ef5-ae97-d68972258e44 (view SPL)AZACTAM (aztreonam for injection, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2012-05-071551541054

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII